00-884. Medical Devices; Exemption From Premarket Notification and Reserved Devices; Class I

[Federal Register Volume 65, Number 10 (Friday, January 14, 2000)]
[Rules and Regulations]
[Pages 2296-2323]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-884]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882,
884, 886, 888, 890, and 892

[Docket No. 98N-0009]

Medical Devices; Exemption From Premarket Notification and
Reserved Devices; Class I

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
classification regulations to designate class I devices that are exempt
from the premarket notification requirements, subject to certain
limitations, and to designate those class I devices that remain subject
to premarket notification requirements under the new statutory criteria
for premarket notification requirements. The devices FDA is designating
as exempt do not include class I devices that have been previously
exempted by regulation from the premarket notification requirements.
This action is being taken under the Federal Food, Drug, and Cosmetic
Act (the act), as amended by the Medical Device Amendments of 1976 (the
1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), and the
FDA Modernization Act of 1997 (FDAMA). FDA is taking this action in
order to implement a requirement of FDAMA. Elsewhere in this issue of
the Federal Register, FDA is announcing that it is withdrawing proposed
rules to revoke existing exemptions from premarket notification for two
devices.

DATES: This regulation is effective February 14, 2000.

FOR FURTHER INFORMATION CONTACT: Heather S. Rosecrans, Center for
Devices and Radiological Health (HFZ-404), Food and Drug
Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594-
1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the act (21 U.S.C. 360c), FDA must classify
devices into one of three regulatory classes: Class I, class II, or
class III. FDA classification of a device is determined by the amount
of regulation necessary to provide a reasonable assurance of safety and
effectiveness. Under the 1976 amendments (Public Law 94-295), as
amended by the SMDA (Public Law 101-629), devices are to be classified
into class I (general controls) if there is information showing that
the general controls of the act are sufficient to ensure safety and
effectiveness; into class II (special controls), if general controls,
by themselves, are insufficient to provide reasonable assurance of
safety and effectiveness, but there is sufficient information to
establish special controls to provide such assurance; and into class
III (premarket approval), if there is insufficient information to
support classifying a device into class I or class II and the device is
a life-sustaining or life-supporting device, or is for a use which is
of substantial importance in preventing impairment of human health, or
presents a potential unreasonable risk of illness or injury.
Most generic types of devices that were on the market before the
date of the 1976 amendments (May 28, 1976) (generally referred to as
preamendments devices) have been classified by FDA under the procedures
set forth in section 513(c) and (d) of the act through the issuance of
classification regulations into one of these three regulatory classes.
Devices introduced into interstate commerce for the first time on or
after May 28, 1976 (generally referred to as postamendments devices)
are classified through the premarket notification process under section
510(k) of the act (21 U.S.C. 360(k)). Section 510(k) of the act and the
implementing regulations, part 807 (21 CFR part 807), require persons
who intend to market a new device to submit a premarket notification
report (510(k)) containing information that allows FDA to determine
whether the new device is substantially equivalent within the meaning
of section 513(i) of the act to a legally marketed device that does not
require premarket approval. Unless exempted from premarket notification
requirements, persons may not market a new device under section 510(k)
of the act, unless they receive a substantial equivalence order from
FDA or an order reclassifying the device into class I or class II,
under section 513(f) of the act.
On November 21, 1997, the President signed FDAMA into law (Public
Law 105-115). Section 206 of FDAMA, in part, added a new section 510(l)
to the act. Under section 206 of FDAMA, new section 510(l) of the act
became effective on February 19, 1998. New section 510(l) of the act
provides that a class I device is exempt from the premarket
notification requirements under section 510(k) of the act, unless the
device is intended for a use which is of substantial importance in
preventing impairment of human health or it presents a potential
unreasonable risk of illness or injury. This document refers to devices
that FDA believes meet these criteria as ``reserved.'' FDA has
evaluated all class I devices to determine which device types should be
subject to premarket notification requirements.
In developing the list of reserved devices, the agency considered
its experience in reviewing premarket notifications for these device
types, focusing on the risk inherent with the device and/or the disease
being treated or diagnosed. FDA believes that the devices listed as
reserved are intended for a use that is of substantial importance in
preventing impairment of human health or present a potential
unreasonable risk of illness or injury.

II. Limitations on Exemptions

FDA believes that the generic types of class I devices listed
herein, in addition to a vast majority of class I devices previously
exempted, should be exempt from the premarket notification requirements
under section 510(l) of the act. FDA further believes, however, that
these generic device categories should be exempt only to the extent
that they have existing or reasonably foreseeable characteristics of
commercially distributed devices within that generic type or, in the
case of in vitro diagnostic devices (IVD's), only to the extent that
misdiagnosis as a result of using the device would not be associated
with high morbidity or mortality. FDA believes that certain changes to
devices within a generic device type that is generally exempt may make
the device intended for a use that is of substantial importance in
preventing impairment of human health or may make the device present a
potential unreasonable risk of illness or injury. Accordingly, devices
changed in this manner would fall within the reserved criteria under
section 510(l) of the act and would require premarket notification.
FDA believes that devices that have different intended uses than
legally marketed devices in that generic device type present a
potential unreasonable risk of illness or injury because their safety
and effectiveness characteristics

[[Page 2297]]

are unknown. Moreover, FDA believes that IVD's are intended for a use
that is of substantial importance in preventing impairment of human
health or present a potential unreasonable risk of illness or injury,
if misdiagnosis, as a result of using the device, could result in high
morbidity or mortality.
Accordingly, because FDA believes that devices incorporating the
characteristics described above fit within the reserved criteria under
section 510(l) of the act, FDA considers any class I device to be
subject to premarket notification requirements if the device: (1) Has
an intended use that is different from the intended use of a legally
marketed device in that generic type of device (e.g., the device is
intended for a different medical purpose, or the device is intended for
lay use instead of use by health care professionals); or (2) operates
using a different fundamental scientific technology than that used by a
legally marketed device in that generic type of device (e.g., a
surgical instrument cuts tissue with a laser beam rather than with a
sharpened metal blade, or an IVD detects or identifies infectious
agents by using a deoxyribonucleic acid (DNA) probe or nucleic acid
hybridization or amplification technology rather than culture or
immunoassay technology); or (3) is an in vitro device that is intended:
(a) For use in the diagnosis, monitoring, or screening of neoplastic
diseases with the exception of immunohistochemical devices; (b) for use
in screening or diagnosis of familial and acquired genetic disorders,
including inborn errors of metabolism; (c) for measuring an analyte
that serves as a surrogate marker for screening, diagnosis, or
monitoring life threatening diseases such as acquired immune deficiency
syndrome (AIDS), chronic or active hepatitis, tuberculosis, or
myocardial infarction or to monitor therapy; (d) to assess the risk of
cardiovascular diseases; (e) for use in diabetes management; (f) to
identify or infer the identity of a microorganism directly from
clinical material; (g) for detection of antibodies to microorganisms
other than immunoglobulin G (IgG) and IgG assays when the results are
not qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma; (h) for
noninvasive testing as defined in Sec. 812.3(k) (21 CFR 812.3(k)); and
(9) for near patient testing (point of care). FDA is revising
Secs. 862.9, 864.9, and 866.9 (21 CFR 862.9, 864.9, and 866.9) to
incorporate these revised limitations on exemptions for IVD's. FDA
believes that these limitations, for the reasons described previously,
are appropriate for IVD's.
FDA is also amending all current limitations on exemptions sections
(21 CFR 862.9, 864.9, 866.9, 868.9, 870.9, 872.9, 874.9, 876.9, 878.9,
880.9, 882.9, 884.9, 886.9, 888.9, 890.9, and 892.9) in two ways.
First, the limitations language clarifies that these limitations apply
to class II, as well as class I devices. On January 21, 1998 (63 FR
3142), FDA published a list of exempted class II devices, subject to
certain limitations. Under section 510(m)(1) of the act, as added by
FDAMA, FDA was provided the authority to exempt these class II devices
from premarket notification upon issuance of a notice. FDA codified
these exemptions, including the limitations described in the January
21, 1998, Federal Register notice, by issuance of a final rule on
November 3, 1998 (63 FR 59222).
The limitations language in this document for class I devices is
identical to those limitations for class II devices that became
effective on January 21, 1998. Accordingly, the limitations sections
state that the scope of these limitations apply to class II, as well as
class I devices.
Second, FDA is amending the limitations language to state that
premarket notifications must be submitted for class I exempt devices if
the intended use is different than the ``legally marketed devices in
that generic type.'' Currently, the limitations in each classification
regulation (e.g., Secs. 862.9, 864.9, etc.) state that manufacturers
must submit premarket notifications for class I exempt devices when
``[t]he device is intended for a use different from its intended use
before May 28, 1976, or the device is intended for a use different from
the intended use of a preamendments device to which it had been
determined to be substantially equivalent;''. Devices that have an
intended use that differs from any legally marketed device are not
exempt because those devices present a potential unreasonable risk of
illness or injury because their safety and effectiveness
characteristics are unknown. Manufacturers of such devices must submit
a premarket notification and the agency will determine if they are
substantially equivalent to other legally marketed devices in that
generic device type.
In addition to the general limitations on exemptions applicable to
all class I devices that are described previously, certain devices
within a generic class also remain subject to the premarket
notification requirements because they either are intended for a use
that is of substantial importance in preventing impairment of human
health or they present a potential unreasonable risk of illness or
injury. For example, elsewhere in this document, FDA states that liquid
bandages are generally exempt from the premarket notification
requirements, but a subcategory of those devices, those intended for
treatment of burns and other open wounds, remains subject to the
premarket notification requirements. FDA believes that liquid bandages
intended for burns and other open wounds should remain subject to this
requirement because they are of substantial importance in preventing
impairment of human health by helping to prevent infections.
FDA also advises that an exemption from the requirement of
premarket notification does not mean that the device is exempt from any
other statutory or regulatory requirements, unless such exemption is
explicitly provided by order or regulation.
The limitations in each classification regulation apply to the
premarket notification exemptions for each generic device classified in
each section. In addition to mentioning the limitations generally in
each classification regulation, FDA specifically states in the
classification sections for each generic device that is newly exempted
under section 510(l) of the act that the exemptions are subject to
limitations. For example, with this regulation Sec. 862.1200 states
that the corticosterone test system ``is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to Sec. 862.9.'' (Emphasis added.) FDA is adding this language
specifically referring to the limitations language for clarity and
convenience.
Individual device classification sections that have been codified
previously that are exempt from premarket notification requirements,
subject to limitations, do not specifically refer to the general
limitations section. For these classifications, FDA intends to codify
language in the near future that will mention the limitations sections
in each device classification.

III. Analysis of Comments

In the Federal Register of February 2, 1998 (63 FR 5387), FDA
published a list of devices it considered reserved and that require
premarket notification and a list of devices it believed met the
exemption criteria in FDAMA. FDA invited comments on the February 2,
1998, notice.
In the Federal Register of November 12, 1998 (63 FR 63222), after
reviewing the comments submitted on the February 2, 1998, Federal
Register

[[Page 2298]]

notice, FDA proposed to designate which devices require premarket
notification, and which are exempt, subject to limitations, under
notice and comment rulemaking proceedings under new section 510(l) of
the act. FDA received four comments in response to the proposed rule.
The following is FDA's response to those comments.
1. One comment in regard to unscented menstrual pads
(Sec. 884.5435) (21 CFR 884.5435)) stated that: (1) Interlabial pads do
not contact vaginal tissue; (2) interlabial pads should not be grouped
with reusable menstrual pads in the regulation because they have
different risks; and (3) the term ``intralabial'' is not accurate and
the correct nomenclature is ``interlabial.''
Both interlabial pads and reusable pads are types of unscented
menstrual pads that meet the reserved criteria, and, therefore, must
meet the premarket notification requirements. Other types of unscented
menstrual pads are exempt. Although FDA agrees that interlabial pads do
not contact vaginal tissue and that interlabial pads present different
risks than reusable menstrual pads, both types of pads still meet the
reserved criteria. FDA did not group these types of pads as reserved
devices because they had the same risks but has determined both need to
undergo premarket review based on their risks independently. FDA agrees
that the term the term ``interlabial'' is more appropriate than the
term ``intralabial'' and is using the term ``interlabial'' in the final
rule and Sec. 884.5435.
2. Another comment requested clarification of the scope of the
classification and exemption of the blood bank centrifuge for in vitro
diagnostic use (Sec. 864.9275 (21 CFR 864.9275)). More specifically,
the comment asked whether centrifuges used to separate whole blood into
its component parts for eventual transfusion to patients are exempt
from premarket notification.
Section 864.9275 applies to the small tabletop centrifuges used to
spin down test tubes of blood samples used in immunohematology tests.
This classification does not include a centrifuge used to separate or
prepare blood components for transfusion, which is classified in class
II as an autotransfusion apparatus (21 CFR 868.5830) and is subject to
premarket notification requirements.
3. One comment requested clarification about how the ``Limitations
to exemption'' apply to a device labeled for general use, such as 21
CFR 862.2300 Colorimeter, photometer, or spectrophotometer for clinical
use or 21 CFR 862.2560 Fluorometer for clinical use. Section 862.9(c)
states the exemption from 510(k) of the act does not apply if the
device is intended, ``for measuring an analyte that serves as a
surrogate marker for screening, diagnosis, or monitoring life-
threatening diseases such as acquired immune deficiency syndrome
(AIDS), chronic or active hepatitis, tuberculosis, or myocardial
infarction or to monitor therapy.''
The ``Limitations to exemption'' refer to the device, as labeled.
If the device has been labeled as a general purpose device, and was
exempt, and it is now to be labeled for a specific indication, such as
cytomegalovirus, a new 510(k) must be submitted and cleared before that
specific indication can be marketed.
4. One comment regarding the ``Limitations to exemption'' objected
to the revocation of the premarket notification exemption for the
cardiopulmonary bypass accessory equipment involving an electrical
connection to the patient prior to up-classifying them into class II in
order to comply with the performance standard for cables and leads. The
comment stated that many of the cardiopulmonary bypass devices did not
involve a cable or lead.
FDA has reviewed the devices that fall under this regulation and
agrees that many of the devices do not involve electrical connections
to the patient. On August 9, 1999 (64 FR 43114), FDA published a
proposed rule to reclassify three devices into class II in order to
make them subject to the performance standard for electrode lead wires
and patient cables. These three devices are: (1) Cardiopulmonary bypass
accessory equipment that involves an electrical connection to the
patient, (2) the goniometer device, and (3) the electrode cable. Under
this proposal, cardiopulmonary bypass accessory equipment that does not
involve an electrical connection to the patient would remain in class I
and would be exempt from the premarket notification requirements.
Because FDA believes that compliance with the performance standard for
electrode lead wires and patient cables would provide adequate
assurance of the safety and effectiveness of these devices, the
proposal provides that these devices would be exempt from the premarket
notification requirements.
Elsewhere in this issue of the Federal Register, FDA is announcing
that it is withdrawing the proposed rules to revoke the exemptions from
premarket notification for cardiopulmonary bypass accessory equipment
and the electrode cable. Under existing 21 CFR 870.4200
(cardiopulmonary bypass accessory equipment) and 21 CFR 890.1175
(electrode cable), these devices are exempt from the premarket
notification requirements. These exemptions will remain in effect. FDA
expects to finalize the August 9, 1999, proposed rule to make these
devices class II shortly after the comment period ends on November 8,
1999. If the rule is finalized, the devices will be exempt from the
premarket notification requirements and all such devices will be
subject to the performance standard for electrode lead wires and
patient cables, when the second phase of that rule becomes effective on
May 9, 2000. FDA believes that there is no reason to make these devices
subject to premarket notification requirements for the short period of
time between the revocation of the exemption from premarket
notification requirements, as proposed in the November 12, 1998,
Federal Register, and the reclassification and exemption from premarket
notification requirements of these devices, as proposed in the August
9, 1999, Federal Register.
The goniometer device is not a subject of this rule and premarket
notification is still required for these devices under existing 21 CFR
888.1500, until the August 9, 1999, rule is finalized.
5. FDA, on its own initiative, is adding all versions of the
keratoscope (21 CFR 886.1350) to the list of devices exempt from
premarket notification requirements. Previously, only keratoscopes that
did not include computer software were exempt from premarket
notification. In the Federal Register of February 2, 1998 (63 FR 5387),
FDA listed a keratoscope with computer software, as a device that it
believed fell under the exemption criteria in section 510(l) of the
act. The proposed rule, however, did not include the keratoscope with
computer software under those devices FDA proposed to codify as exempt.
Subsequent to the issuance of the proposed rule, FDA received an
inquiry concerning the exemption status of this device. Upon
consideration, FDA does not believe that the keratoscope with computer
software is intended for a use that is of substantial importance in
preventing impairment of human health or that it presents a potential
unreasonable risk of illness or injury and therefore it is exempt from
the premarket notification requirements.
6. FDA, on its own initiative, has made some minor changes in the
sections of each classification, which describe the limitations to
exemptions from section 510(k) of the act. In these sections, FDA lists
certain intended uses or changes that will preclude a device

[[Page 2299]]

from falling within an exemption that is otherwise applicable to a
generic class of devices.
In the final rule, FDA made some nonsubstantive changes in the
introductory paragraph that clarify FDA's reasons for the types of
limitations listed. In proposed sections of each classification
regulation, FDA explained that it listed the limitations because those
types of changes were unforeseeable, and, therefore could significantly
affect safety and effectiveness. The final rule clarifies that FDA also
listed certain types of limitations because any misdiagnosis using
devices for the listed intended uses may be associated with high
morbidity or mortality.
In addition, FDA has made minor changes in describing two of the
intended uses of in vitro devices that would require a premarket
notification. Proposed limitations in paragraph (c)(2) stated that
premarket notifications must be submitted when a device is an in vitro
device that is intended for use in ``screening or diagnosis of familial
and acquired genetic disorders, including inborn errors of
metabolism.'' (Emphasis added.) The proposed rule may have been
interpreted to require premarket notification for only devices that
were used in screening or diagnosis of both familial and acquired
genetic disorders.
FDA intended that devices used in connection with either familial
or acquired genetic disorders be subject to premarket notification
requirements because misdiagnosis of either of these disorders would be
associated with high morbidity or mortality. Accordingly, FDA has
amended the final rule in each limitation section of each
classification regulation to state that premarket notifications must be
submitted when a device is an in vitro device that is intended for use
in ``screening or diagnosis of familial or acquired genetic disorders,
including inborn errors of metabolism.'' (Emphasis added.)
Similarly, FDA stated in the proposed limitation in paragraph
(c)(7) that it would require premarket notification for in vitro
devices intended for detection of antibodies to microorganisms other
than immunoglobulin G (IgG) and IgG assays when the results are not
qualitative * * *.'' The proposed rule could be interpreted to require
premarket notification unless the device were intended for detection of
both IgG and IgG assays. FDA is amending the final rule in the
limitation in paragraph (c)(7) by replacing the word ``and'' with
``or'' to indicate that if an exempt in vitro device is intended to
detect antibodies to either IgG or IgG assays, the device will remain
exempt.
7. FDA, on its own initiative, has added language clarifying the
description of exempted devices in Sec. 880.5090 Liquid bandage (21 CFR
880.5090), Sec. 886.4070 Powered corneal burr (21 CFR 886.4070), and
Sec. 886.4750 Ophthalmic eye shield (21 CFR 886.4750). The proposed
classification descriptions state that the devices were exempt from
premarket notification requirements when used for certain intended
uses. FDA has added language to clarify that the exemption applies only
when the device is used exclusively for the intended uses stated in the
classification descriptions.
For example, proposed Sec. 880.5090 Liquid bandage stated: ``When
used as a skin protectant, the device is exempt from premarket
notification procedures.'' FDA amended final Sec. 880.5090 by adding
the word ``only'' to the text to clarify that if the device were
intended for a use in addition to protecting skin, it would not qualify
for the exemption. Accordingly, final Sec. 880.5090 states: ``When used
only as a skin protectant, the device is exempt from premarket
notification procedures.'' Similarly, FDA has amended final
Secs. 886.4070 Powered corneal burr and 886.4750 Ophthalmic eye shield
by adding the word ``only'' to clarify the exemption does not apply
when the device is used for intended uses not specifically stated in
the regulation.
8. Also, on its own initiative, FDA is revising the description of
the exempted device, rubber dam, in 21 CFR 872.6300(a) to clarify that
this device does not include a rubber dam, which is intended for
prevention of sexually transmitted diseases during oral sex. Such a
device is classified as a condom in 21 CFR 884.5300.

IV. Designation of Devices

The following devices are devices that FDA believes meet the
reserved criteria in section 206 of FDAMA and, therefore, FDA is
codifying the determination that they remain subject to premarket
notification under new section 510(l) of the act:

Table 1--Designations of Reserved Class I Devices
----------------------------------------------------------------------------------------------------------------
21 CFR Section Name of Device
----------------------------------------------------------------------------------------------------------------
862.1065 Ammonia test system
862.1113 Bilirubin (total and unbound) in the neonate test system
862.1310 Galactose test system
862.1410 Iron (non-heme) test system
862.1415 Iron-binding capacity test system
862.1495 Magnesium test system
862.1580 Phosphorous (inorganic) test system
862.1660 Quality control material (assayed and unassayed) ¹
862.1680 Testosterone test system
862.1730 Free tyrosine test system
862.1775 Uric acid test system
862.3050 Breath-alcohol test system
862.3110 Antimony test system
862.3120 Arsenic test system
862.3220 Carbon monoxide test system
862.3240 Cholinesterase test system
862.3280 Clinical toxicology control material (assayed and unassayed) ¹
862.3600 Mercury test system
862.3750 Quinine test system
862.3850 Sulfonamide test system
864.7040 Adenosine triphosphate release assay
864.8950 Russell viper venom reagent
864.9050 Blood bank supplies
864.9125 Vacuum-assisted blood collection system ²
864.9195 Blood mixing devices and blood weighing devices ²

[[Page 2300]]

866.2390 Transport culture medium
866.2560 Microbial growth monitor ³
866.2850 Automated zone reader
866.2900 Microbiological specimen collection and transport device
866.3110 Campylobacter fetus serological reagents
866.3120 Chlamydia serological reagents
866.3235 Epstein-Barr virus serological reagents
866.3370 Mycobacterium tuberculosis immunofluorescent reagents
866.3870 Trypanosoma spp. serological reagents
872.3700 Dental mercury
872.4200 Dental handpiece and accessories
872.6250 Dental chair and accessories ⁴
872.6640 Dental operative unit and accessories ⁵
872.6710 Boiling water sterilizer
876.5160 Urological clamps for males ⁶
878.4460 Surgeon's glove
880.5090 Liquid bandage ⁷
880.5680 Pediatric position holder
880.6250 Patient examination glove
880.6375 Patient lubricant
880.6760 Protective restraint
882.1030 Ataxiagraph
882.1420 Electroencephalogram (EEG) signal spectrum analyzer
882.4060 Ventricular cannula ⁸
882.4545 Shunt system implantation instrument ⁹
884.2980(a) Telethermographic system ¹⁰
884.2982(a) Liquid crystal thermographic system ¹¹
884.5435 Unscented menstrual pads (interlabial pads and reusable
menstrual pads)
886.4070 Powered corneal burr ¹²
886.4300 Intraocular lens guide ¹³
886.4370 Keratome
886.4750 Ophthalmic eye shield (when made of other than plastic or
aluminum)
888.1500 Goniometer
890.3850 Mechanical wheelchair
890.5710 Hot or cold disposable pack ¹⁴
892.1100 Scintillation (gamma) camera
892.1110 Positron camera
----------------------------------------------------------------------------------------------------------------
\1\ Meets reserved criteria for all assayed and only the unassayed when used for donor screening.
\2\ Meets reserved criteria when automated.
\3\ Meets reserved criteria when automated blood culturing systems.
\4\ Meets reserved criteria when dental chair with the operative unit.
\5\ Meets reserved criteria when it is not an accessory to the unit.
\6\ Meets reserved criteria when devices are for internal use or are used for females.
\7\ Meets reserved criteria for uses other than as a skin protectant.
\8\ Meets reserved criteria if not made of surgical grade stainless steel.
\9\ Meets reserved criteria if not made of surgical grade stainless steel.
\10\ Meets reserved criteria if an adjunct use system.
\11\ Meets reserved criteria if nonelectrically powered or AC-powered adjunctive system.
\12\ Meets reserved criteria if for use other than for removing rust rings.
\13\ Meets reserved criteria if used as folders or injectors for soft or foldable intraocular lenses (IOL's).
\14\ Meets reserved criteria if indicated for use on infants.

FDA is amending the regulations to designate the following devices
as exempt from premarket notification because FDA believes that they do
not meet the reserved criteria under new section 510(l) of the act:

Table 2--Designations of Exempted Class I Devices
----------------------------------------------------------------------------------------------------------------
21 CFR Section Name of Device
----------------------------------------------------------------------------------------------------------------
862.1030 Alanine amino transferase (ALT/SGPT) test system
862.1040 Aldolase test system
862.1060 Delta-aminolevulinic acid test system
862.1075 Androstenedione test system
862.1080 Androsterone test system
862.1095 Ascorbic acid test system
862.1115 Urinary bilirubin and its conjugates (nonquantitative) test
system
862.1130 Blood volume test system
862.1135 C-peptides of proinsulin test system
862.1165 Catecholamines (total) test system
862.1175 Cholesterol (total) test
862.1180 Chymotrypsin test system
862.1185 Compound S (11-deoxycortisol) test system
862.1195 Corticoids test system

[[Page 2301]]

862.1200 Corticosterone test system
862.1240 Cystine test system
862.1245 Dehydroepiandrosterone (free and sulfate) test system
862.1250 Desoxycorticosterone test system
862.1260 Estradiol test system
862.1265 Estriol test system
862.1270 Estrogens (total, in pregnancy) test system
862.1275 Estrogens (total, nonpregnancy) test system
862.1280 Estrone test system
862.1285 Etiocholanolone test system
862.1300 Follicle-stimulating hormone test system
862.1325 Gastrin test system
862.1330 Globulin test system
862.1335 Glucagon test system
862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system
862.1370 Human growth hormone test system
862.1375 Histidine test system
862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test system
862.1390 5-Hydroxyindole acetic acid/serotonin test system
862.1395 17-Hydroxyprogesterone test system
862.1400 Hydroxyproline test system
862.1405 Immunoreactive insulin test system
862.1430 17-Ketosteroids test system
862.1435 Ketones (nonquantitative) test system
862.1450 Lactic acid test system
862.1460 Leucine aminopeptidase test system
862.1465 Lipase test system
862.1475 Lipoprotein test system
862.1485 Luteinizing hormone test system
862.1500 Malic dehydrogenase test system
862.1505 Mucopolysaccharides (nonquantitative) test system
862.1510 Nitrite (nonquantitative) test system
862.1520 5'-Nucleotidase test system
862.1530 Plasma oncometry test system
862.1535 Ornithine carbamyl transferase test system
862.1540 Osmolality test system
862.1542 Oxalate test system
862.1550 Urinary pH (nonquantitative) test system
862.1560 Urinary phenylketones (nonquantitative) test system
862.1570 Phosphohexose isomerase test system
862.1590 Porphobilinogen test system
862.1595 Porphyrins test system
862.1605 Pregnanediol test system
862.1610 Pregnanetriol test system
862.1615 Pregnenolone test system
862.1620 Progesterone test system
862.1625 Prolactin (lactogen) test system
862.1630 Protein (fractionation) test system
862.1645 Urinary protein or albumin (nonquantitative) test system
862.1650 Pyruvate kinase test system
862.1655 Pyruvic acid test system
862.1660 Quality control material (assayed and unassayed) ¹
862.1705 Triglyceride test system
862.1725 Trypsin test system
862.1780 Urinary calculi (stones) test system
862.1785 Urinary urobilinogen (nonquantitative) test system
862.1790 Uroporphyrin test system
862.1795 Vanilmandelic acid test system
862.1805 Vitamin A test system
862.1820 Xylose test system
862.2140 Centrifugal chemistry analyzer for clinical use
862.2150 Continuous flow sequential multiple chemistry analyzer for
clinical use
862.2160 Discrete photometric chemistry analyzer for clinical use
862.2170 Micro chemistry analyzer for clinical use
862.2250 Gas liquid chromatography system for clinical use
862.2260 High pressure liquid chromatography system for clinical use
862.2270 Thin-layer chromatography system for clinical use
862.2300 Colorimeter, photometer, or spectrophotometer for clinical use
862.2400 Densitometer/scanner (integrating, reflectance, TLC, or
radiochromatogram) for clinical use
862.2500 Enzyme analyzer for clinical use
862.2540 Flame emission photometer for clinical use

[[Page 2302]]

862.2560 Fluorometer for clinical use
862.2680 Microtitrator for clinical use
862.2700 Nephelometer for clinical use
862.2730 Osmometer for clinical use
862.2750 Pipetting and diluting system for clinical use
862.2850 Atomic absorption spectrophotometer for clinical use
862.2860 Mass spectrometer for clinical use
862.2900 Automated urinalysis system
862.3280 Clinical toxicology control material (assayed and unassayed) ¹
864.2280 Cultured animal and human cells
864.3250 Specimen transport and storage container
864.5240 Automated blood cell diluting apparatus
864.6150 Capillary blood collection tube
864.9125 Vacuum-assisted blood collection system ²
864.9185 Blood grouping view box
864.9195 Blood mixing devices and blood weighing devices ²
864.9225 Cell-freezing apparatus and reagents for in vitro diagnostic
use
864.9275 Blood bank centrifuge for in vitro diagnostic use
864.9320 Copper sulphate solution for specific gravity determinations
864.9750 Heat-sealing device
866.2660 Microorganism differentiation and identification device
866.3040 Aspergillus spp. serological reagents
866.3140 Corynebacterium spp. serological reagents
866.3145 Coxsackievirus serological reagents
866.3200 Echinococcus spp. serological reagents
866.3240 Equine encephalomyelitis virus serological reagents
866.3355 Listeria spp. serological reagents
866.3360 Lymphocytic choriomeningitis virus serological reagents
866.3375 Mycoplasma spp. serological reagents
866.3380 Mumps virus serological reagents
866.3405 Poliovirus serological reagents
866.3480 Respiratory syncytial virus serological reagents
866.3500 Rickettsia serological reagents
866.3600 Schistosoma spp. serological reagents
866.3680 Sporothrix schenckii serological reagents
866.3740 Streptococcus spp. serological reagents
866.3850 Trichinella spiralis serological reagents
866.5060 Prealbumin immunological test system
866.5065 Human allotypic marker immunological test system
866.5160 Beta-globulin immunological test system
866.5200 Carbonic anhydrase B and C immunological test
866.5330 Factor XIII, A, S, immunological test system ³
866.5400 Alpha-globulin immunological test system
866.5420 Alpha-1-glycoproteins immunological test system
866.5425 Alpha-2-glycoproteins immunological test system
866.5430 Beta-2-glycoprotein I immunological test system
866.5440 Beta-2-glycoprotein III immunological test system
866.5560 Lactic dehydrogenase immunological test system
866.5570 Lactoferrin immunological test system
866.5590 Lipoprotein X immunological test system
866.5715 Plasminogen immunological test system
866.5735 Prothrombin immunological test system ⁴
866.5765 Retinol-binding protein immunological test system
866.5890 Inter-alpha trypsin inhibitor immunological test system
868.1910 Esophageal stethoscope
868.5620 Breathing mouthpiece
868.5640 Medicinal nonventilatory nebulizer (atomizer)
868.5675 Rebreathing device
868.5700 Nonpowered oxygen tent
868.6810 Tracheobronchial suction catheter
872.3275(a)(1) Dental cement (zinc oxide-eugenol)
872.3400(b)(1) Karaya and sodium borate with or without acacia denture
adhesive (less than 12 percent sodium borate by weight)
872.3540(b)(1) OTC denture cushion or pad ⁵
872.6300 Rubber dam and accessories ⁶
872.6390 Dental floss
874.1070 Short increment sensitivity index (SISI) adapter
874.1100 Earphone cushion for audiometric testing
874.1500 Gustometer
874.1800 Air or water caloric stimulator
874.1925 Toynbee diagnostic tube
874.3300(b)(1) Hearing aid ⁷

[[Page 2303]]

874.3540 Prosthesis modification instrument for ossicular replacement
surgery
874.4100 Epistaxis balloon
874.4420 Ear, nose, and throat manual surgical instrument
874.5300 Ear, nose, and throat examination and treatment unit
874.5550 Powered nasal irrigator
874.5840 Antistammering device
876.5160 Urological clamp for males ⁸
876.5210 Enema kit
876.5250(b)(2) Urine collector and accessories ⁹
876.5980(b)(2) Gastrointestinal tube and accessories ¹⁰
878.3250 External facial fracture fixation appliance
878.3910 Noninflatable extremity splint
878.3925 Plastic surgery kit and accessories
878.4040 Surgical apparel ¹¹
878.4100 Organ bag
878.4200 Introduction/drainage catheter and accessories
878.4320 Removable skin clip
878.4680 Nonpowered, single patient, portable suction apparatus
878.4760 Removable skin staple
878.4820 Surgical instrument motors and accessories/attachments
878.4960 Operating tables and accessories and operating chairs and
accessories
880.5090 Liquid bandage ¹²
880.5270 Neonatal eye pad
880.5420 Pressure infusor for an I.V. bag
882.1200 Two-point discriminator
882.1500 Esthesiometer
882.1750 Pinwheel
882.4060 Ventricular cannula ¹³
882.4545 Shunt system implantation instrument ¹⁴
882.4650 Neurosurgical suture needle
882.4750 Skull punch ¹⁵
884.1040 Viscometer for cervical mucus
886.1350 Keratoscope
886.1780 Retinoscope ¹⁶
886.1940 Tonometer sterilizer
886.4070 Powered corneal burr ¹⁷
886.4300 Intraocular lens guide ¹⁸
886.5850 Sunglasses (nonprescription)
890.5180 Manual patient rotation bed
890.5710 Hot or cold disposable pack ¹⁹
892.1300 Nuclear rectilinear scanner
892.1320 Nuclear uptake probe
892.1330 Nuclear whole body scanner
892.1350 Nuclear scanning bed
892.1410 Nuclear electrocardiograph synchronizer
892.1890 Radiographic film illuminator
892.1910 Radiographic grid
892.1960 Radiographic intensifying screen
892.1970 Radiographic ECG/respirator, synchronizer
892.2010 Medical image storage device
892.2020 Medical image communications device
892.5650 Manual radionuclide applicator system
892.6500 Personnel protective shield
----------------------------------------------------------------------------------------------------------------
\1\ Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.
\2\ Exemption is limited to manual devices.
\3\ This exemption should not be confused with 21 CFR 864.7290.
\4\ This exemption should not be confused with 21 CFR 864.5425 or 864.7750.
\5\ This exemption does not apply to class III OTC denture cushion as described in 21 CFR 872.3540(b)(2).
\6\ Exemption does not include rubber dam intended for use in preventing transmission of sexually transmitted
diseases through oral sex. Those devices are classified as condoms in 21 CFR 884.5300.
\7\ Exemption is limited to air-conduction hearing aids.
\8\ Exemption does not include devices for internal use or devices used for females.
\9\ Exemption does not include class II devices for a urine collector and accessories intended to be connected
to an indwelling catheter as described in 21 CFR 876.5250(b)(1).
\10\ Exemption is limited to dissolvable nasogastric feed tube guide for the nasogastric tube in 21 CFR
876.5980(b)(2). Exemption does not include class II devices as described in Sec. 876.5980(b)(1).
\11\ Exemption is limited to class I category other than surgical gowns and surgical masks.
\12\ Exemption is limited to uses as a skin protectant.
\13\ Exemption is limited to devices made of surgical grade stainless steel.
\14\ Exemption is limited to devices made of surgical grade stainless steel.
\15\ Exemption should not be confused with 21 CFR 882.4305.
\16\ Exemption is limited to class I battery-powered devices.
\17\ Exemption is limited to rust ring removal.

[[Page 2304]]

\18\ Exemption does not apply if used as folders and injectors for soft or foldable IOL's.
\19\ Exemption does not apply if intended for use on infants

V. Environmental Impact

The agency has determined under 21 CFR 25.30(h) that these actions
are of a type that do not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.

VI. Analysis of Impacts

FDA has examined the impacts of the final rule under Executive
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), as
amended by subtitle D of the Small Business Regulatory Fairness Act of
1996 (Public Law 104-121), and the Unfunded Mandates Reform Act of 1995
(Public Law 104-4). Executive Order 12866 directs agencies to assess
all costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety and other advantages distributive impacts and
equity). The agency believes that this rule is consistent with the
regulatory philosophy and principles identified in the Executive Order.
In addition, the rule is not a significant regulatory action as defined
by the Executive Order and so is not subject to review under the
Executive Order.
The Regulatory Flexibility Act requires, if a rule has a
significant impact on a substantial number of small entities, agencies
to analyze regulatory options that would minimize any significant
impact of a rule on small entities. In most cases, the rule would
reduce a regulatory burden by exempting manufacturers of devices
subject to the rule from the requirements of premarket notification.
FDA is requiring premarket notification for three devices that were
previously exempt from premarket notification. These devices are as
follows:

A. Ophthalmic Eye Shield (When Made of Other Than Plastic or Aluminum)
(Sec. 886.4750).

There are six manufacturers of ophthalmic eye shields other than
those made of plastic or aluminum registered with FDA. FDA anticipates
that any premarket notifications that are necessary for these devices
would be simple because FDA would be primarily interested in
information about biocompatibility. FDA estimates that preparation of
such a premarket notification would cost no more than $5,000 and that
there would be no more than 6 premarket notifications per year for a
total annual cost of $30,000.
Six manufacturers are not a substantial number of entities. Based
on data compiled by the Small Business Administration, optical goods
firms with fewer than 500 employees have annual receipts of $1,524,000.
Therefore, the cost per firm of complying with this regulation ($5,000)
does not have a significant impact on these small entities.

B. Quinine Test System (Sec. 862.3750) and Sulfonamide Test System
(Sec. 862.3850).

At this time, there are no firms registered for manufacture of
these devices.
In light of the previous discussion, under the Regulatory
Flexibility Act (5 U.S.C. 605(b)), the agency certifies that the final
rule will not have a significant economic impact on a substantial
number of small entities. The rule also does not trigger the
requirement for a written statement under section 202(a) of the
Unfunded Mandates Reform Act because it does not impose a mandate that
results in an expenditure of $100 million or more by State, local, or
tribal governments in the aggregate, or by the private sector, in any
one year.

VII. Paperwork Reduction Act of 1995

FDA concludes that this rule contains no collections of
information. Therefore, clearance by the Office of Management and
Budget under the Paperwork Reduction Act of 1995 is not required.

List of Subjects

21 CFR Parts 862, 868, 870, 872, 874, 876, 878, 880, 882, 884, 888, and
890

Medical devices.

21 CFR Part 864

Biologics, Blood, Laboratories, Medical devices, Packaging and
containers.

21 CFR Part 866

Biologics, Laboratories, Medical devices.

21 CFR Part 886

Medical devices, Ophthalmic goods and services.

21 CFR Part 892

Medical devices, Radiation protection, X-rays.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
862, 864, 866, 868, 870, 872, 874, 876, 878, 880, 882, 884, 886, 888,
890, and 892 are amended as follows:

PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

1. The authority citation for 21 CFR part 862 continues to read as
follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
2. Section 862.9 is revised to read as follows:

Sec. 862.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

[[Page 2305]]

(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
3. Section 862.1030 is amended by revising paragraph (b) to read as
follows:

Sec. 862.1030 Alanine amino transferase (ALT/SGPT) test system.

Sec. 862.1040 Aldolase test system.

Sec. 862.1060 Delta-aminolevulinic acid test system.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from premarket notification procedures in subpart E of part 807
of this chapter subject to Sec. 862.9.
6. Section 862.1075 is amended by revising paragraph (b) to read as
follows:

Sec. 862.1075 Androstenedione test system.

Sec. 862.1080 Androsterone test system.

Sec. 862.1095 Ascorbic acid test system.

Sec. 862.1115 Urinary bilirubin and its conjugates (nonquantitative)
test system.

Sec. 862.1130 Blood volume test system.

Sec. 862.1135 C-peptides of proinsulin test system.

Sec. 862.1165 Catecholamines (total) test system.

Sec. 862.1175 Cholesterol (total) test system.

Sec. 862.1180 Chymotrypsin test system.

Sec. 862.1185 Compound S (11-deoxycortisol) test system.

Sec. 862.1195 Corticoids test system.

Sec. 862.1200 Corticosterone test system.

Sec. 862.1240 Cystine test system.

Sec. 862.1245 Dehydroepiandrosterone (free and sulfate) test system.

* * * * *

[[Page 2306]]

(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 862.9.
20. Section 862.1250 is amended by revising paragraph (b) to read
as follows:

Sec. 862.1250 Desoxycorticosterone test system.

Sec. 862.1260 Estradiol test system.

Sec. 862.1265 Estriol test system.

Sec. 862.1270 Estrogens (total, in pregnancy) test system.

Sec. 862.1275 Estrogens (total, nonpregnancy) test system.

Sec. 862.1280 Estrone test system.

Sec. 862.1285 Etiocholanolone test system.

Sec. 862.1300 Follicle-stimulating hormone test system.

Sec. 862.1325 Gastrin test system.

Sec. 862.1330 Globulin test system.

Sec. 862.1335 Glucagon test system.

Sec. 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test
system.

Sec. 862.1370 Human growth hormone test system.

Sec. 862.1375 Histidine test system.

Sec. 862.1385 17-Hydroxycorticosteroids (17-ketogenic steroids) test
system.

Sec. 862.1390 5-Hydroxyindole acetic acid/serotonin test system.

Sec. 862.1395 17-Hydroxyprogesterone test system.

Sec. 862.1400 Hydroxyproline test system.

Sec. 862.1405 Immunoreactive insulin test system.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the

[[Page 2307]]

premarket notification procedures in subpart E of part 807 of this
chapter subject to Sec. 862.9.
39. Section 862.1430 is amended by revising paragraph (b) to read
as follows:

Sec. 862.1430 17-Ketosteroids test system.

Sec. 862.1435 Ketones (nonquantitative) test system.

Sec. 862.1450 Lactic acid test system.

Sec. 862.1460 Leucine aminopeptidase test system.

Sec. 862.1465 Lipase test system.

Sec. 862.1475 Lipoprotein test system.

Sec. 862.1485 Luteinizing hormone test system.

Sec. 862.1500 Malic dehydrogenase test system.

Sec. 862.1505 Mucopolysaccharides (nonquantitative) test system.

Sec. 862.1510 Nitrite (nonquantitative) test system.

Sec. 862.1520 5'-Nucleotidase test system.

Sec. 862.1530 Plasma oncometry test system.

Sec. 862.1535 Ornithine carbamyl transferase test system.

Sec. 862.1540 Osmolality test system.

Sec. 862.1542 Oxalate test system.

Sec. 862.1550 Urinary pH (nonquantitative) test system.

Sec. 862.1560 Urinary phenylketones (nonquantitative) test system.

Sec. 862.1570 Phosphohexose isomerase test system.

Sec. 862.1590 Porphobilinogen test system.

Sec. 862.1595 Porphyrins test system.

* * * * *

[[Page 2308]]

(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 862.9.
59. Section 862.1605 is amended by revising paragraph (b) to read
as follows:

Sec. 862.1605 Pregnanediol test system.

Sec. 862.1610 Pregnanetriol test system.

Sec. 862.1615 Pregnenolone test system.

Sec. 862.1620 Progesterone test system.

Sec. 862.1625 Prolactin (lactogen) test system.

Sec. 862.1630 Protein (fractionation) test system.

Sec. 862.1645 Urinary protein or albumin (nonquantitative) test
system.

Sec. 862.1650 Pyruvate kinase test system.

Sec. 862.1655 Pyruvic acid test system.

Sec. 862.1660 Quality control material (assayed and unassayed).

* * * * *
(b) Classification. Class I (general controls). Except when used
in donor screening tests, unassayed material is exempt from the
premarket notification procedures in subpart E of part 807 of this
chapter subject to Sec. 862.9.
69. Section 862.1705 is amended by revising paragraph (b) to read
as follows:

Sec. 862.1705 Triglyceride test system.

Sec. 862.1725 Trypsin test system.

Sec. 862.1780 Urinary calculi (stones) test system.

Sec. 862.1785 Urinary urobilinogen (nonquantitative) test system.

Sec. 862.1790 Uroporphyrin test system.

Sec. 862.1795 Vanilmandelic acid test system.

Sec. 862.1805 Vitamin A test system.

Sec. 862.1820 Xylose test system.

Sec. 862.2140 Centrifugal chemistry analyzer for clinical use.

Sec. 862.2150 Continuous flow sequential multiple chemistry analyzer
for clinical use.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the

[[Page 2309]]

premarket notification procedures in subpart E of part 807 of this
chapter subject to Sec. 862.9.
79. Section 862.2160 is amended by revising paragraph (b) to read
as follows:

Sec. 862.2160 Discrete photometric chemistry analyzer for clinical
use.

Sec. 862.2170 Micro chemistry analyzer for clinical use.

Sec. 862.2250 Gas liquid chromatography system for clinical use.

Sec. 862.2260 High pressure liquid chromatography system for clinical
use.

Sec. 862.2270 Thin-layer chromatography system for clinical use.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 862.9. Particular components of TLC
systems, i.e., the thin-layer chromatography apparatus, TLC atomizer,
TLC developing tanks, and TLC ultraviolet light, are exempt from the
current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180 of this chapter, with
respect to general requirements concerning records, and Sec. 820.198 of
this chapter, with respect to complaint files.
84. Section 862.2300 is amended by revising paragraph (b) to read
as follows:

Sec. 862.2300 Colorimeter, photometer, or spectrophotometer for
clinical use.

Sec. 862.2400 Densitometer/scanner (integrating, reflectance, TLC, or
radiochromatogram) for clinical use.

Sec. 862.2500 Enzyme analyzer for clinical use.

Sec. 862.2540 Flame emission photometer for clinical use.

Sec. 862.2560 Fluorometer for clinical use.

Sec. 862.2680 Microtitrator for clinical use.

Sec. 862.2700 Nephelometer for clinical use.

Sec. 862.2730 Osmometer for clinical use.

Sec. 862.2750 Pipetting and diluting system for clinical use.

Sec. 862.2850 Atomic absorption spectrophotometer for clinical use.

Sec. 862.2860 Mass spectrometer for clinical use.

Sec. 862.2900 Automated urinalysis system.

Sec. 862.3280 Clinical toxicology control material.

* * * * *
(b) Classification. Class I (general controls). Except when used
in donor screening, unassayed material is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to Sec. 862.9.
97. Section 862.3750 is amended by revising paragraph (b) to read
as follows:

[[Page 2310]]

Sec. 862.3750 Quinine test system.

* * * * *
(b) Classification. Class I.
98. Section 862.3850 is amended by revising paragraph (b) to read
as follows:

Sec. 862.3850 Sulfonamide test system.

* * * * *
(b) Classification. Class I.

PART 864--HEMATOLOGY AND PATHOLOGY DEVICES

99. The authority citation for 21 CFR part 864 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

100. Section 864.9 is revised to read as follows:

Sec. 864.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
101. Section 864.2280 is amended by revising paragraph (b) to read
as follows:

Sec. 864.2280 Cultured animal and human cells.

Sec. 864.3250 Specimen transport and storage container.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 864.9. If the device is not labeled
or otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with
the exception of Sec. 820.180 of this chapter, with respect to general
requirements concerning records, and Sec. 820.198 of this chapter, with
respect to complaint files.
103. Section 864.5240 is amended by revising paragraph (b) to read
as follows:

Sec. 864.5240 Automated blood cell diluting apparatus.

Sec. 864.6150 Capillary blood collection tube.

Sec. 864.9125 Vacuum-assisted blood collection system.

* * * * *
(b) Classification. Class I (general controls). The manual device
is exempt from the premarket notification procedures in subpart E of
part 807 of this chapter subject to Sec. 864.9.
106. Section 864.9185 is amended by revising paragraph (b) to read
as follows:

Sec. 864.9185 Blood grouping view box.

Sec. 864.9195 Blood mixing devices and blood weighing devices.

* * * * *
(b) Classification. Class I (general controls). The manual device
is exempt from the premarket notification procedures in subpart E of
part 807 of this chapter subject to Sec. 864.9.
108. Section 864.9225 is amended by revising paragraph (b) to read
as follows:

Sec. 864.9225 Cell-freezing apparatus and reagents for in vitro
diagnostic use.

Sec. 864.9275 Blood bank centrifuge for in vitro diagnostic use.

[[Page 2311]]

Sec. 864.9320 Copper sulfate solution for specific gravity
determinations.

Sec. 864.9750 Heat-sealing device.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 864.9.

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

112. The authority citation for 21 CFR part 866 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

113. Section 866.9 is revised to read as follows:

Sec. 866.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
114. Section 866.2660 is amended by revising paragraph (b) to read
as follows:

Sec. 866.2660 Microorganism differentiation and identification device.

Sec. 866.3040 Aspergillus spp. serological reagents.

Sec. 866.3140 Corynebacterium spp. serological reagents.

Sec. 866.3145 Coxsackievirus serological reagents.

Sec. 866.3200 Echinococcus spp. serological reagents.

Sec. 866.3240 Equine encephalomyelitis virus serological reagents.

Sec. 866.3355 Listeria spp. serological reagents.

Sec. 866.3360 Lymphocytic choriomeningitis virus serological reagents.

Sec. 866.3375 Mycoplasma spp. serological reagents.

[[Page 2312]]

Sec. 866.3380 Mumps virus serological reagents.

Sec. 866.3405 Poliovirus serological reagents.

Sec. 866.3480 Respiratory syncytial virus serological reagents.

Sec. 866.3500 Rickettsia serological reagents.

Sec. 866.3600 Schistosoma spp. serological reagents.

Sec. 866.3680 Sporothrix schenckii serological reagents.

Sec. 866.3740 Streptococcus spp. serological reagents.

Sec. 866.3850 Trichinella spiralis serological reagents.

Sec. 866.5060 Prealbumin immunological test system.

Sec. 866.5065 Human allotypic marker immunological test system.

Sec. 866.5160 Beta-globulin immunological test system.

Sec. 866.5200 Carbonic anhydrase B and C immunological test system.

Sec. 866.5330 Factor XIII, A, S, immunological test system.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 866.9. This exemption does not
apply to factor deficiency tests classified under Sec. 864.7290 of this
chapter.
136. Section 866.5400 is amended by revising paragraph (b) to read
as follows:

Sec. 866.5400 Alpha-globulin immunological test system.

Sec. 866.5420 Alpha-1-glycoproteins immunological test system.

Sec. 866.5425 Alpha-2-glycoproteins immunological test system.

Sec. 866.5430 Beta-2-glycoprotein I immunological test system.

Sec. 866.5440 Beta-2-glycoprotein III immunological test system.

Sec. 866.5560 Lactic dehydrogenase immunological test system.

[[Page 2313]]

Sec. 866.5570 Lactoferrin immunological test system.

Sec. 866.5590 Lipoprotein X immunological test system.

Sec. 866.5715 Plasminogen immunological test system.

Sec. 866.5735 Prothrombin immunological test system.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 866.9. This exemption does not
apply to multipurpose systems for in vitro coagulation studies
classified under Sec. 864.5425 of this chapter or prothrombin time
tests classified under Sec. 864.7750 of this chapter.
146. Section 866.5765 is amended by revising paragraph (b) to read
as follows:

Sec. 866.5765 Retinol-binding protein immunological test system.

Sec. 866.5890 Inter-alpha trypsin inhibitor immunological test system.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 866.9.

PART 868--ANESTHESIOLOGY DEVICES

148. The authority citation for 21 CFR part 868 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

149. Section 868.9 is revised to read as follows:

Sec. 868.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
150. Section 868.1910 is amended by revising paragraph (b) to read
as follows:

Sec. 868.1910 Esophageal stethoscope.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 868.9.
151. Section 868.5620 is amended by revising paragraph (b) to read
as follows:

Sec. 868.5620 Breathing mouthpiece.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 868.9.
152. Section 868.5640 is amended by revising paragraph (b) to read
as follows:

Sec. 868.5640 Medicinal nonventilatory nebulizer (atomizer).

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 868.9.
153. Section 868.5675 is amended by revising paragraph (b) to read
as follows:

Sec. 868.5675 Rebreathing device.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 868.9.
154. Section 868.5700 is amended by revising paragraph (b) to read
as follows:

Sec. 868.5700 Nonpowered oxygen tent.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in

[[Page 2314]]

subpart E of part 807 of this chapter subject to Sec. 868.9.
155. Section 868.6810 is amended by revising paragraph (b) to read
as follows:

Sec. 868.6810 Tracheobronchial suction catheter.

* * * * *
(b) Classification. Class 1 (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 868.9.

PART 870--CARDIOVASCULAR DEVICES

156. The authority citation for 21 CFR part 870 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

157. Section 870.9 is revised to read as follows:

Sec. 870.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

PART 872--DENTAL DEVICES

158. The authority citation for 21 CFR part 872 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

159. Section 872.9 is revised to read as follows:

Sec. 872.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
160. Section 872.3275 is amended by revising paragraph (a)(2) to
read as follows:

Sec. 872.3275 Dental cement.

(a) * * *
(2) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 872.9.
* * * * *

[[Page 2315]]

161. Section 872.3400 is amended by revising paragraph (b)(1) to
read as follows:

Sec. 872.3400 Karaya and sodium borate with or without acacia denture
adhesive.

* * * * *
(b) Classification. (1) Class I (general controls) if the device
contains less than 12 percent by weight of sodium borate. The class I
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to Sec. 872.9.
* * * * *
162. Section 872.3540 is amended by revising paragraph (b)(1) to
read as follows:

Sec. 872.3540 OTC denture cushion or pad.

* * * * *
(b) Classification. (1) Class I if the device is made of wax-
impregnated cotton cloth that the patient applies to the base or inner
surface of a denture before inserting the denture into the mouth. The
device is intended to be discarded following 1 day's use. The class I
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to Sec. 872.9.
* * * * *
163. Section 872.6300 is revised to read as follows:

Sec. 872.6300 Rubber dam and accessories.

(a) Identification. A rubber dam and accessories is a device
composed of a thin sheet of latex with a hole in the center intended to
isolate a tooth from fluids in the mouth during dental procedures, such
as filling a cavity preparation. The device is stretched around a tooth
by inserting a tooth through a hole in the center. The device includes
the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a
rubber dam clamp. This classification does not include devices intended
for use in preventing transmission of sexually transmitted diseases
through oral sex; those devices are classified as condoms in
Sec. 884.5300 of this chapter.
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 872.9. If the device is not labeled
or otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with
the exception of Sec. 820.180 of this chapter, with respect to general
requirements concerning records, and Sec. 820.198 of this chapter, with
respect to complaint files.
164. Section 872.6390 is amended by revising paragraph (b) to read
as follows:

Sec. 872.6390 Dental floss.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 872.9.
165. Section 872.6640 is amended by revising paragraph (b) to read
as follows:

Sec. 872.6640 Dental operative unit and accessories.

* * * * *
(b) Classification. Class I (general controls). Except for dental
operative unit, accessories are exempt from premarket notification
procedures in subpart E of part 807 of this chapter subject to
Sec. 872.9.

PART 874--EAR, NOSE, AND THROAT DEVICES

166. The authority citation for 21 CFR part 874 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

167. Section 874.9 is revised to read as follows:

Sec. 874.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
168. Section 874.1070 is amended by revising paragraph (b) to read
as follows:

Sec. 874.1070 Short increment sensitivity index (SISI) adapter.

Sec. 874.1100 Earphone cushion for audiometric testing.

Sec. 874.1500 Gustometer.

* * * * *

[[Page 2316]]

(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 874.9. If the device is not labeled
or otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with
the exception of Sec. 820.180 of this chapter, with respect to general
requirements concerning records, and Sec. 820.198 of this chapter, with
respect to complaint files.
171. Section 874.1800 is amended by revising paragraph (b) to read
as follows:

Sec. 874.1800 Air or water caloric stimulator.

Sec. 874.1925 Toynbee diagnostic tube.

Sec. 874.3300 Hearing Aid.

* * * * *
(b) Classification. (1) Class I (general controls) for the air-
conduction hearing aid. The air-conduction hearing aid is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to Sec. 874.9.
(2) Class II for the bone-conduction hearing aid.
174. Section 874.3540 is amended by revising paragraph (b) to read
as follows:

Sec. 874.3540 Prosthesis modification instrument for ossicular
replacement surgery.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 874.9. If the device is not labeled
or otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with
the exception of Sec. 820.180 of this chapter, with respect to general
requirements concerning records, and Sec. 820.198 of this chapter, with
respect to complaint files.
175. Section 874.4100 is amended by revising paragraph (b) to read
as follows:

Sec. 874.4100 Epistaxis balloon.

* * * * *
(b) Classification Class I (general controls). The device is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to Sec. 874.9.
176. Section 874.4420 is amended by revising paragraph (b) to read
as follows:

Sec. 874.4420 Ear, nose, and throat manual surgical instrument.

Sec. 874.5300 Ear, nose, and throat examination and treatment unit.

Sec. 874.5550 Powered nasal irrigator.

Sec. 874.5840 Antistammering device.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 874.9.

PART 876--GASTROENTEROLOGY-UROLOGY DEVICES

180. The authority citation for 21 CFR part 876 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

181. Section 876.9 is revised to read as follows:

Sec. 876.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

[[Page 2317]]

(9) For near patient testing (point of care).
182. Section 876.5160 is amended by revising paragraph (b) to read
as follows:

Sec. 876.5160 Urological clamp for males.

* * * * *
(b) Classification. Class I (general controls). Except when
intended for internal use or use on females, the device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to Sec. 876.9.
183. Section 876.5210 is amended by revising paragraph (b) to read
as follows:

Sec. 876.5210 Enema kit.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 876.9. The device is exempt from
the current good manufacturing practice regulations in part 820 of this
chapter, with the exception of Sec. 820.180 of this chapter, with
respect to general requirements concerning records, and Sec. 820.198 of
this chapter, with respect to complaint files.
184. Section 876.5250 is amended by revising paragraph (b)(2) to
read as follows:

Sec. 876.5250 Urine collector and accessories.

* * * * *
(b) * * *
(2) Class I (general controls) for a urine collector and
accessories not intended to be connected to an indwelling catheter. The
class I device is exempt from the premarket notification procedures in
subpart E of part 807 of this chapter subject to Sec. 876.9. If the
device is not labeled or otherwise represented as sterile, it is exempt
from the current good manufacturing practice regulations in part 820 of
this chapter, with the exception of Sec. 820.180 of this chapter, with
respect to the general requirements concerning records, and
Sec. 820.198 of this chapter, with respect to complaint files.
185. Section 876.5980 is amended by revising paragraph (b)(2) to
read as follows:

Sec. 876.5980 Gastrointestinal tube and accessories.

* * * * *
(b) * * *
(2) Class I (general controls) for the dissolvable nasogastric
feed tube guide for the nasogastric tube. The class I device is exempt
from the premarket notification procedures in subpart E of part 807 of
this chapter subject to Sec. 876.9.

PART 878--GENERAL AND PLASTIC SURGERY DEVICES

186. The authority citation for 21 CFR part 878 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

187. Section 878.9 is revised to read as follows:

Sec. 878.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
188. Section 878.3250 is amended by revising paragraph (b) to read
as follows:

Sec. 878.3250 External facial fracture fixation appliance.

Sec. 878.3910 Noninflatable extremity splint.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 878.9. If the device is not labeled
or otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with
the exception of Sec. 820.180 of this chapter, with respect to general
requirements concerning records, and Sec. 820.198 of this chapter, with
respect to complaint files.
190. Section 878.3925 is amended by revising paragraph (b) to read
as follows:

Sec. 878.3925 Plastic surgery kit and accessories.

[[Page 2318]]

Sec. 878.4040 Surgical apparel.

* * * * *
(b) Classification. (1) Class II (special controls) for surgical
gowns and surgical masks.
(2) Class I (general controls) for surgical apparel other than
surgical gowns and surgical masks. The class I device is exempt from
the premarket notification procedures in subpart E of part 807 of this
chapter subject to Sec. 878.9.
192. Section 878.4100 is amended by revising paragraph (b) to read
as follows:

Sec. 878.4100 Organ bag.

Sec. 878.4200 Introduction/drainage catheter and accessories.

Sec. 878.4320 Removable skin clip.

Sec. 878.4680 Nonpowered, single patient, portable suction apparatus.

Sec. 878.4760 Removable skin staple.

Sec. 878.4820 Surgical instrument motors and accessories/attachments.

Sec. 878.4960 Operating tables and accessories and operating chairs
and accessories.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 878.9.

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

199. The authority citation for 21 CFR part 880 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

200. Section 880.9 is revised to read as follows:

Sec. 880.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
201. Section 880.5090 is amended by revising paragraph (b) to read
as follows:

Sec. 880.5090 Liquid bandage.

* * * * *
(b) Classification. Class I (general controls). When used only as a
skin protectant, the device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to
Sec. 880.9.
202. Section 880.5270 is amended by revising paragraph (b) to read
as follows:

Sec. 880.5270 Neonatal eye pad.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 880.9. If the device is not labeled
or otherwise represented as sterile, it is exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with
the exception of Sec. 820.180 of this chapter, with respect to general
requirements concerning records, and Sec. 820.198 of this chapter, with
respect to complaint files.

[[Page 2319]]

203. Section 880.5420 is amended by revising paragraph (b) to read
as follows:

Sec. 880.5420 Pressure infusor for an I.V. bag.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 880.9.

PART 882--NEUROLOGICAL DEVICES

204. The authority citation for 21 CFR part 882 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

205. Section 882.9 is revised to read as follows:

Sec. 882.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
206. Section 882.1200 is amended by revising paragraph (b) to read
as follows:

Sec. 882.1200 Two-point discriminator.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 882.9. The device is also exempt
from the current good manufacturing practice regulations in part 820 of
this chapter, with the exception of Sec. 820.180 of this chapter, with
respect to general requirements concerning records, and Sec. 820.198 of
this chapter, with respect to complaint files.
207. Section 882.1500 is amended by revising paragraph (b) to read
as follows:

Sec. 882.1500 Esthesiometer.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 882.9. The device is also exempt
from the current good manufacturing practice regulations in part 820 of
this chapter, with the exception of Sec. 820.180 of this chapter, with
respect to general requirements concerning records, and Sec. 820.198 of
this chapter, with respect to complaint files.
208. Section 882.1750 is amended by revising paragraph (b) to read
as follows:

Sec. 882.1750 Pinwheel.

Sec. 882.4060 Ventricular cannula.

* * * * *
(b) Classification. Class I (general controls). When made only of
surgical grade stainless steel, the device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to Sec. 882.9.
210. Section 882.4545 is amended by revising paragraph (b) to read
as follows:

Sec. 882.4545 Shunt system implantation instrument.

* * * * *
(b) Classification. Class I (general controls). When made only of
surgical grade stainless steel, the device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to Sec. 882.9.
211. Section 882.4650 is amended by revising paragraph (b) to read
as follows:

Sec. 882.4650 Neurosurgical suture needle.

Sec. 882.4750 Skull punch.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 882.9. This exemption does not
apply to powered compound cranial drills, burrs, trephines, and their
accessories classified under Sec. 882.4305.

PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES

213. The authority citation for 21 CFR part 884 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

214. Section 884.9 is revised to read as follows:

Sec. 884.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I

[[Page 2320]]

or II device is only to the extent that the device has existing or
reasonably foreseeable characteristics of commercially distributed
devices within that generic type or, in the case of in vitro diagnostic
devices, only to the extent that misdiagnosis as a result of using the
device would not be associated with high morbidity or mortality.
Accordingly, manufacturers of any commercially distributed class I or
II device for which FDA has granted an exemption from the requirement
of premarket notification must still submit a premarket notification to
FDA before introducing or delivering for introduction into interstate
commerce for commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
215. Section 884.1040 is amended by revising paragraph (b) to read
as follows:

Sec. 884.1040 Viscometer for cervical mucus.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 884.9.

Sec. 884.5435 [Amended]

216. Section 884.5435 Unscented menstrual pad is amended in the
last sentence of paragraph (b) by removing the word ``intralabial'' and
adding in its place the word ``interlabial''.

PART 886--OPHTHALMIC DEVICES

217. The authority citation for 21 CFR part 886 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

218. Section 886.9 is revised to read as follows:

Sec. 886.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
219. Section 886.1350 is amended by revising paragraph (b) to read
as follows:

Sec. 886.1350 Keratoscope.

* * * * *
(b) The device is exempt from the premarket notification procedures
in subpart E of part 807 of this chapter subject to Sec. 886.9. The
battery-powered device is exempt from the current good manufacturing
practice regulations in part 820 of this chapter, with the exception of
Sec. 820.180 of this chapter, with respect to general requirements
concerning records, and Sec. 820.198 of this chapter, with respect to
complaint files
220. Section 886.1780 is amended by revising paragraph (b) to read
as follows:

Sec. 886.1780 Retinoscope.

* * * * *
(b) Classification. (1) Class II (special controls) for the AC-
powered device.
(2) Class I (general controls) for the battery-powered device. The
class I

[[Page 2321]]

battery-powered device is exempt from the premarket notification
procedures in subpart E of part 807 of this chapter subject to
Sec. 886.9. The battery-powered device is exempt from the current good
manufacturing practice regulations in part 820 of this chapter, with
the exception of Sec. 820.180 of this chapter, with respect to general
requirements concerning records, and Sec. 820.198 of this chapter, with
respect to complaint files.
221. Section 886.1940 is amended by revising paragraph (b) to read
as follows:

Sec. 886.1940 Tonometer sterilizer.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 886.9.
222. Section 886.4070 is amended by revising paragraph (b) to read
as follows:

Sec. 886.4070 Powered corneal burr.

* * * * *
(b) Classification. Class I (general controls). When intended only
for rust ring removal, the device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to Sec. 886.9.
223. Section 886.4300 is amended by revising paragraph (b) to read
as follows:

Sec. 886.4300 Intraocular lens guide.

* * * * *
(b) Classification. Class I (general controls). Except when used
as folders or injectors for soft or foldable intraocular lenses, the
device is exempt from the premarket notification procedures in subpart
E of part 807 of this chapter subject to Sec. 886.9.
224. Section 886.4750 is amended by revising paragraph (b) to read
as follows:

Sec. 886.4750 Ophthalmic eye shield.

* * * * *
(b) Classification. Class I (general controls). When made only of
plastic or aluminum, the device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to Sec. 886.9. When made only of plastic or aluminum, the
devices are exempt from the current good manufacturing practice
regulations in part 820 of this chapter, with the exception of
Sec. 820.180 of this chapter, with respect to general requirements
concerning records, and Sec. 820.198 of this chapter, with respect to
complaint files.
225. Section 886.5850 is amended by revising paragraph (b) to read
as follows:

Sec. 886.5850 Sunglasses (nonprescription).

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 886.9.

PART 888--ORTHOPEDIC DEVICES

226. The authority citation for 21 CFR part 888 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

227. Section 888.9 is revised to read as follows:

Sec. 888.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

PART 890--PHYSICAL MEDICINE DEVICES

228. The authority citation for 21 CFR part 890 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

229. Section 890.9 is revised to read as follows:

Sec. 890.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

[[Page 2322]]

purpose, or the device is intended for lay use where the former
intended use was by health care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
230. Section 890.5180 is amended by revising paragraph (b) to read
as follows:

Sec. 890.5180 Manual patient rotation bed.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 890.9.
231. Section 890.5710 is amended by revising paragraph (b) to read
as follows:

Sec. 890.5710 Hot or cold disposable pack.

* * * * *
(b) Classification. Class I (general controls). Except when
intended for use on infants, the device is exempt from the premarket
notification procedures in subpart E of part 807 of this chapter
subject to Sec. 890.9.

PART 892--RADIOLOGY DEVICES

232. The authority citation for 21 CFR part 892 continues to read
as follows:

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

233. Section 892.9 is revised to read as follows:

Sec. 892.9 Limitations of exemptions from section 510(k) of the
Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification
(section 510(k) of the act) for a generic type of class I or II device
is only to the extent that the device has existing or reasonably
foreseeable characteristics of commercially distributed devices within
that generic type or, in the case of in vitro diagnostic devices, only
to the extent that misdiagnosis as a result of using the device would
not be associated with high morbidity or mortality. Accordingly,
manufacturers of any commercially distributed class I or II device for
which FDA has granted an exemption from the requirement of premarket
notification must still submit a premarket notification to FDA before
introducing or delivering for introduction into interstate commerce for
commercial distribution the device when:
(a) The device is intended for a use different from the intended
use of a legally marketed device in that generic type of device; e.g.,
the device is intended for a different medical purpose, or the device
is intended for lay use where the former intended use was by health
care professionals only;
(b) The modified device operates using a different fundamental
scientific technology than a legally marketed device in that generic
type of device; e.g., a surgical instrument cuts tissue with a laser
beam rather than with a sharpened metal blade, or an in vitro
diagnostic device detects or identifies infectious agents by using
deoxyribonucleic acid (DNA) probe or nucleic acid hybridization
technology rather than culture or immunoassay technology; or
(c) The device is an in vitro device that is intended:
(1) For use in the diagnosis, monitoring, or screening of
neoplastic diseases with the exception of immunohistochemical devices;
(2) For use in screening or diagnosis of familial or acquired
genetic disorders, including inborn errors of metabolism;
(3) For measuring an analyte that serves as a surrogate marker for
screening, diagnosis, or monitoring life-threatening diseases such as
acquired immune deficiency syndrome (AIDS), chronic or active
hepatitis, tuberculosis, or myocardial infarction or to monitor
therapy;
(4) For assessing the risk of cardiovascular diseases;
(5) For use in diabetes management;
(6) For identifying or inferring the identity of a microorganism
directly from clinical material;
(7) For detection of antibodies to microorganisms other than
immunoglobulin G (IgG) or IgG assays when the results are not
qualitative, or are used to determine immunity, or the assay is
intended for use in matrices other than serum or plasma;
(8) For noninvasive testing as defined in Sec. 812.3(k) of this
chapter; and
(9) For near patient testing (point of care).
234. Section 892.1300 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1300 Nuclear rectilinear scanner.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
235. Section 892.1320 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1320 Nuclear uptake probe.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
236. Section 892.1330 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1330 Nuclear whole body scanner.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
237. Section 892.1350 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1350 Nuclear scanning bed.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
238. Section 892.1410 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1410 Nuclear electrocardiograph synchronizer.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the

[[Page 2323]]

premarket notification procedures in subpart E of part 807 of this
chapter subject to Sec. 892.9.
239. Section 892.1890 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1890 Radiographic film illuminator.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
240. Section 892.1910 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1910 Radiographic grid.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
241. Section 892.1960 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1960 Radiographic intensifying screen.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
242. Section 892.1970 is amended by revising paragraph (b) to read
as follows:

Sec. 892.1970 Radiographic ECG/respirator synchronizer.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
243. Section 892.2010 is amended by revising paragraph (b) to read
as follows:

Sec. 892.2010 Medical image storage device.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
244. Section 892.2020 is amended by revising paragraph (b) to read
as follows:

Sec. 892.2020 Medical image communications device.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
245. Section 892.5650 is amended by revising paragraph (b) to read
as follows:

Sec. 892.5650 Manual radionuclide applicator system.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.
246. Section 892.6500 is amended by revising paragraph (b) to read
as follows:

Sec. 892.6500 Personnel protective shield.

* * * * *
(b) Classification. Class I (general controls). The device is
exempt from the premarket notification procedures in subpart E of part
807 of this chapter subject to Sec. 892.9.

Dated: December 22, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-884 Filed 1-13-00; 8:45 am]
BILLING CODE 4160-01-F

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Document Information

Effective Date:: 2/14/2000
Published:: 01/14/2000
Department:: Food and Drug Administration
Entry Type:: Rule
Action:: Final rule.
Document Number:: 00-884
Dates:: This regulation is effective February 14, 2000.
Pages:: 2296-2323 (28 pages)
Docket Numbers:: Docket No. 98N-0009
PDF File:: 00-884.pdf
CFR: (233): 21 CFR 864.9185; 21 CFR 864.9195; 21 CFR 864.9225; 21 CFR 864.9275; 21 CFR 864.9320; More ...